Cytokinetics heart drug aficamten succeeds in pivotal trial
27 Dec 2023
AcquisitionPhase 3Clinical ResultAHADrug Approval
Cytokinetics said Wednesday that aficamten significantly improved exercise capacity compared to placebo in a pivotal study of patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Shares in the drugmaker jumped more than 80% on the news.
CEO Robert Blum indicated that marketing submissions for aficamten are planned in the second half of 2024. Leerink Partners analysts recently suggested that peak sales of the drug could reach $3 billion by 2035.
All secondary goals hit
Top-line results from the Phase III SEQUOIA-HCM trial showed that compared to placebo, aficamten increased peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing by a least square mean difference of 1.74 mL/kg/min, hitting the study’s primary endpoint. Cytokinetics noted that the treatment effect with aficamten was consistent across all prespecified subgroups.
The company added that statistically significant improvements were seen for all 10 prespecified secondary endpoints, including Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), as well as the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class. Meanwhile, aficamten had an adverse-event profile comparable to placebo in the trial, with no instances of worsening heart failure or treatment interruptions due to low left ventricular ejection fraction (LVEF).
Cadian myosin inhibitor of choice?
“The results…meet our high expectations… and may reflect a profile enabling of aficamten to become the cardiac myosin inhibitorcardiac myosin inhibitor of choice among physicians and patients,” remarked Fady Malik, Cytokinetics’ executive vice president of R&D. The once-daily oral drug is also being studied in the Phase III MAPLE-HCM trial, which is comparing aficamten to metoprolol in patients with symptomatic obstructive HCM, as well as the late-stage ACACIA-HCM study in subjects with symptomatic non-obstructive HCM.
Last year, the FDA approved Bristol Myers Squibb’s Camzyos (mavacamten) to improve functional capacity and symptoms in adults with symptomatic NYHA class II-III obstructive HCM. The company gained the allosteric and reversible selective inhibitor of cardiac myosin by way of its $13.1-billion purchase of MyoKardiaMyoKardia in 2020. Meanwhile, Cytokinetics is also seen as an acquisition target, with recent rumours of takeover interest from AstraZeneca and Novartis.
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